This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Alcon has issued a letter to affected customers recommending certain Alcon Custom Paks be removed from where they are used or sold. 

Affected devices:

What to Do

Locate and dispose of any affected lots of Alcon Custom Pak remaining in your inventory. 

On November 24, Alcon sent all affected customers a letter recommending the following actions: 

  • Review your inventory to determine if you have any unused affected product within your facility.
  • Segregate and dispose of any unused affected product from your inventory. 
  • Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 
  • Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.

Reason for Recall

Images of product with incomplete seal.

Alcon stated that impacted lots may contain pouches with incomplete seals. Due to the risk that the sterile barrier may be compromised, Alcon is recalling potentially affected lots. The use of non-sterile surgical products may increase the risk of microbial contamination and subsequent ocular infection which may necessitate additional medical attention.

As of December 18, Alcon has not reported any serious injuries or deaths associated with this issue.

Device Use

Alcon Custom Paks are customer-designed, sterile surgical procedure packs/convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the materials necessary to perform an ophthalmic surgical procedure.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Alcon through https://notifeye.alcon.com/external/s/ or call 1-800-757-9780 and select option 5.

Additional FDA Resources:

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.